Dexamethasone-implant for the Treatment of RVO
NCT01767545 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2013-01-14
Summary
To evaluate the efficacy and safety of a dexamethasone-implant alone or in combination with bevacizumab. 64 eyes are prospectively investigated. Group 1 (22 CRVO and 16 BRVO) is treated with dexamethasone-implant alone, Group 2 (14 CRVO 12 BRVO) with three consecutive bevacizumab injections followed by a dexamethasone-implant. Recurrences are treated with dexamethasone-implant only. Patients are seen preoperatively and thereafter in monthly intervals. The primary endpoint was BCVA at twelve months.
Conditions
- Macular Edema Caused by Retinal Vein Occlusion
Interventions
- DRUG
-
Dexamethasone implant
- DRUG
Sponsors & Collaborators
-
Ludwig-Maximilians - University of Munich
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 20 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-09-30
- Primary Completion
- 2011-01-31
- Completion
- 2012-02-29
Countries
- Germany
Study Locations
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